5010AI Platform Terms and Conditions

Effective Date: April 02, 2026

These Terms and Conditions (“Terms”) govern the use of the 5010AI regulatory intelligence platform, including all AI-powered tools, analytics dashboards, and data services (collectively, the “Services” or “Platform”) provided by 5010AI LLC (“5010AI,” “Company,” “we,” or “us”). By ordering or using the Services, you (“Customer,” “you,” or “your”) agree to be bound by these Terms (together with any Order Form executed by you and accepted by 5010AI, the “Agreement”). If you are entering into this Agreement on behalf of an organization, you represent that you have authority to bind that organization. If you do not agree to these Terms, do not use the Services.

1. Order Forms and Acceptance

1.1 Ordering Process:

To obtain access to the Services, you must submit a completed 5010AI Order Form or place an order through an approved channel. All Order Forms are subject to acceptance by 5010AI. An order becomes binding when 5010AI provides written acceptance or commences service delivery (for example, by providing access credentials or an invoice). You agree to be bound by the terms of any accepted Order Form.

1.2 Binding Commitment:

Once accepted, an Order Form (including the subscription term) is non-cancellable and non-modifiable by you except with our written consent. You represent and warrant that any individual submitting an Order Form or purchase order on your behalf is duly authorized to bind you. Invoices will be issued for all accepted orders, and you agree to pay all Fees as provided in Section 9 below.

1.3 Order of Precedence:

If there is any conflict between these Terms and an Order Form, the Order Form controls only with respect to specific order details (such as fees, term, and service tiers), and these Terms govern all other aspects of the relationship. Any additional or different terms in your purchase orders or other documents are void unless explicitly accepted in writing by 5010AI.

2. Description of Services

2.1 Platform Overview:

The Services consist of a regulatory intelligence platform delivered via a secure web portal. The Platform includes AI-powered analysis tools, self-service analytics dashboards, curated regulatory datasets, and related documentation. Specific tools and features available to you are determined by your Order Form and subscription tier.

2.2 AI-Powered Tools:

The Platform may include tools that use artificial intelligence, including large language models, to generate analysis, reports, and insights based on regulatory, clinical, and competitive data. These tools may retrieve and synthesize information from curated proprietary datasets as well as publicly available sources (such as FDA, EMA, ClinicalTrials.gov, PubMed, and openFDA databases). AI-generated content is produced automatically and is subject to the disclaimers in Section 5 and Section 11.

2.3 Analytics and Data Dashboards:

The Platform may include interactive analytics dashboards, data visualizations, and query tools that allow you to explore curated regulatory and clinical datasets. These dashboards display data derived from publicly available regulatory sources and 5010AI’s proprietary data processing. Data currency, completeness, and accuracy are subject to the limitations of the underlying sources.

2.4 News and Intelligence Feeds:

The Platform may include curated news feeds, regulatory alerts, and intelligence digests drawn from publicly available sources. These are provided for informational purposes and do not constitute professional advice.

3. License Grant and Restrictions

3.1 License Grant:

Subject to your compliance with these Terms (including timely payment of fees), 5010AI grants you a limited, non-exclusive, non-transferable, non-sublicensable right to access and use the Services during the Term for your internal business purposes. All rights not expressly granted are reserved by 5010AI.

3.2 Scope of Use:

You may only access the Services using the credentials issued to you and for the use cases permitted by your subscription tier. You may not distribute, resell, lease, or sublicense the Services or allow unauthorized third parties to use them. Use of AI-generated outputs (“Outputs”) is limited to your internal business purposes unless otherwise agreed in writing.

3.3 Intellectual Property:

5010AI retains all rights, title, and interest in and to the Services, including all underlying software, curated datasets, data processing methodologies, models, technology, and documentation. Nothing in these Terms grants you any ownership right in the Services or underlying data. As between you and 5010AI, you retain ownership of any data you input into the Platform (“Input”), and you own the Outputs generated specifically for you, subject to the restrictions in these Terms. You grant 5010AI a limited license to use your Input solely to provide the Services and comply with applicable law.

3.4 License Restrictions:

You agree not to (a) copy, modify, or create derivative works of the Services or any part of them (except as specifically permitted); (b) reverse engineer, decompile, or disassemble the Services or any underlying AI models; (c) transfer or lease the Services to any third party; (d) use the Services to build a competing product or service; (e) systematically download, scrape, or bulk-export data from the Platform; (f) attempt to circumvent usage limits, access controls, or security measures; or (g) use the Services in any manner not expressly permitted by this Agreement. Breach of these restrictions is grounds for immediate termination.

4. Customer Obligations

4.1 Authorized Use:

You are responsible for all activities performed under your accounts and access credentials. You will ensure that only authorized users (e.g., your employees or agents) access the Services. You will prevent unauthorized use and promptly notify 5010AI of any security breach or unauthorized access.

4.2 Lawful Use:

You shall use the Services only for lawful purposes and in compliance with all applicable laws and regulations, including those governing pharmaceutical development, regulatory submissions, and clinical research. You agree not to use the Services to generate content that is defamatory, obscene, illegal, infringing, or misleading, or to facilitate any illegal activity.

4.3 Data Responsibility:

You are solely responsible for the accuracy, completeness, and legality of the Input data you provide. You must ensure that you have all necessary rights and consents to input such data (including personal or confidential data) and to have the Services process it. You are responsible for notifying affected individuals, as required by law, about the use of their data. The obligations in 5010AI’s Data Processing Addendum (if applicable) and these Terms regarding privacy and data protection do not relieve you of your obligations to comply with privacy laws.

4.4 Output Review and Verification:

The Platform uses artificial intelligence, including large language models, to generate analysis and content. AI-generated Outputs may contain inaccuracies, omissions, or errors (“hallucinations”). You must review and verify all AI-generated Outputs before relying on them. You agree not to use any Output as a sole basis for regulatory submissions, clinical trial design decisions, drug development strategy, legal compliance determinations, medical decisions, financial decisions, or other consequential actions. You remain solely responsible for all decisions made or actions taken based on the Outputs. You should apply qualified human judgment and, where appropriate, consult independent experts to validate AI-generated content.

4.5 Usage Limits:

Your use of the Services is subject to any usage limits, rate limits, or fair use thresholds specified in your Order Form or published usage policies. 5010AI reserves the right to throttle or temporarily restrict access if usage materially exceeds normal patterns or threatens platform stability. 5010AI will use commercially reasonable efforts to notify you before imposing such restrictions.

5. AI Features, Beta Features, and Data Sources

5.1 AI Features:

The Services include artificial intelligence capabilities powered by third-party large language models and 5010AI’s proprietary data processing. These features may generate reports, analyses, summaries, and insights based on regulatory and clinical data. You acknowledge that AI technology has inherent limitations and that Outputs may not always be unique, complete, or fully accurate.

5.2 Third-Party Data Sources:

The Platform retrieves and processes data from publicly available sources, including but not limited to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), ClinicalTrials.gov, PubMed, and the openFDA API. 5010AI does not control these sources and makes no representations regarding their accuracy, completeness, timeliness, or continued availability. Changes to third-party data sources, APIs, or access policies may affect the functionality or content of the Services. 5010AI will use commercially reasonable efforts to maintain data currency but does not guarantee real-time accuracy.

5.3 Third-Party Service Providers:

The Services rely on third-party infrastructure and service providers for hosting, data delivery, and AI processing. 5010AI is not liable for failures, outages, or performance degradation caused by third-party service providers. 5010AI will use commercially reasonable efforts to select reliable providers and to notify you of material disruptions.

5.4 Beta and Experimental Features:

5010AI may label certain new features as “beta,” “pilot,” “experimental,” or similar. Beta Features are provided on a trial or preview basis, “AS IS” and “AS AVAILABLE,” without any warranties. 5010AI may modify or discontinue Beta Features at any time without notice. 5010AI will have no liability for your use of Beta Features. Feedback on Beta Features is governed by Section 8.

5.5 Output Disclaimer:

Any content or output generated by the AI features of the Platform (collectively, “AI Output”) is for general informational purposes only. AI Output is produced automatically and may contain errors, omissions, or hallucinations. 5010AI does not guarantee the correctness, completeness, or appropriateness of any AI Output. AI Output does not constitute regulatory advice, clinical guidance, legal advice, or any form of professional recommendation. You are solely responsible for verifying and validating all AI Output. Decisions made based on AI Output are your responsibility, and you remain accountable for complying with all applicable laws and regulations.

5.6 Prohibited Uses:

You agree not to use the AI features of the Services to: (a) generate or disseminate defamatory, harassing, obscene, hateful, violent, or otherwise illegal or harmful content; (b) facilitate criminal, fraudulent, or unethical activities; (c) infringe any third party’s intellectual property or privacy rights; (d) input or request generation of sensitive personal data (e.g., individually identifiable patient data, health records, biometric data) unless you are fully authorized and compliant with all applicable privacy and health data laws; (e) submit AI-generated Outputs directly to regulatory authorities (such as FDA or EMA) as original work product without appropriate human review and disclosure; (f) represent AI-generated Outputs to third parties as human-authored professional analysis without disclosure; or (g) attempt to reverse-engineer, extract training data from, or misuse the underlying AI models.

6. Data Privacy and Protection

6.1 Compliance with Privacy Laws:

Each party will comply with applicable data privacy and protection laws in connection with the Services, including the EU General Data Protection Regulation (GDPR), the UK GDPR, and applicable U.S. state and federal privacy laws. You will obtain all necessary consents and provide all required notices for processing personal data through the Services.

6.2 Data Processing:

If you use the Services to process personal data, you are the “Controller” and 5010AI is a “Processor” under GDPR and similar laws. 5010AI’s obligations as Processor are set forth in the Data Processing Addendum (DPA) incorporated into this Agreement. You remain responsible for compliance with data protection laws, including ensuring that processing is lawful and that data subjects’ rights can be exercised. 5010AI will implement reasonable technical and organizational measures to protect personal data.

6.3 Data Retention and Deletion:

5010AI will retain Customer Input and AI Output data only for as long as necessary to provide the Services and comply with applicable law. Upon termination of the Agreement, 5010AI will, at your written request, delete or return your data within thirty (30) days, except where retention is required by law or necessary for 5010AI’s legitimate compliance purposes. Aggregated, anonymized, or de-identified data that cannot reasonably be used to identify you or any individual may be retained for service improvement purposes.

6.4 Security:

5010AI will maintain appropriate security measures (including encryption in transit and at rest, access controls, and monitoring) to protect the confidentiality and integrity of data processed by the Services. No internet or data storage system is fully secure, and 5010AI does not guarantee absolute security. In the event of a data breach affecting your data, 5010AI will notify you promptly as required by law and work to remediate the issue.

6.5 AI Data Processing:

Customer Input submitted to AI features may be transmitted to third-party AI model providers for processing. 5010AI ensures that such providers are contractually bound to appropriate data protection obligations. Customer Input is not used to train third-party AI models unless you separately consent. 5010AI does not retain logs of individual AI queries beyond what is necessary for service delivery and troubleshooting.

7. Confidentiality

7.1 Definition:

“Confidential Information” means non-public information disclosed by one party (“Discloser”) to the other (“Recipient”) that is marked confidential or that should reasonably be understood as confidential given its nature. Confidential Information includes business plans, technology, trade secrets, and Customer data. Customer Input and AI Output (except Output that is already public) are your Confidential Information. 5010AI’s model architecture, datasets, data processing methodologies, algorithms, and software are 5010AI’s Confidential Information.

7.2 Nondisclosure Obligations:

Each party agrees not to use the other’s Confidential Information for any purpose other than performing its obligations under these Terms. The Recipient will protect the Discloser’s Confidential Information using the same degree of care it uses to protect its own confidential information (but in no event less than reasonable care). Confidential Information may only be disclosed to employees or contractors who need to know it and who are bound by confidentiality obligations no less strict than those herein.

7.3 Exclusions:

Confidential Information does not include information that (a) was or becomes publicly available through no breach by Recipient; (b) was rightfully in Recipient’s possession prior to disclosure; (c) was rightfully received from a third party without confidentiality restrictions; or (d) was independently developed by Recipient without use of the other’s information.

7.4 Required Disclosure:

If Recipient is compelled by law to disclose Confidential Information, it will give Discloser prompt notice (if legally permitted) and cooperate with Discloser’s efforts to limit or contest the disclosure.

7.5 Survival:

Confidentiality obligations survive termination of this Agreement for five (5) years (or longer if required by law).

8. Feedback

If you provide suggestions, ideas, enhancement requests, or other feedback regarding the Services (“Feedback”), you grant 5010AI a non-exclusive, royalty-free, worldwide, perpetual license to use, incorporate, and commercialize such Feedback without restriction or obligation to you. Feedback does not constitute your Confidential Information.

9. Fees and Payment

9.1 Fees:

You agree to pay all fees and charges set forth in each Order Form (“Fees”). Unless otherwise specified, 5010AI will invoice you for all Fees due at the start of your subscription term or as otherwise agreed. Fees are quoted in U.S. dollars (USD) unless another currency is specified.

9.2 Payment:

Payment is due within thirty (30) days of invoice date (or as otherwise stated in the Order Form). No setoff or withholding is allowed. Timely payment is a condition of your access to the Services. If you fail to pay any undisputed invoice by its due date, 5010AI may suspend or terminate your access until payment is made. Overdue amounts accrue interest at 1.5% per month (or the maximum permitted by law).

9.3 Taxes:

Fees are exclusive of taxes, duties, and charges. You are responsible for all taxes (including VAT, sales, use, and withholding taxes) associated with your purchase or use of the Services, except for taxes based on 5010AI’s net income.

9.4 No Refunds:

Except as expressly provided in this Agreement or required by law, all payments are non-refundable. Your obligation to pay Fees is not contingent on the delivery of any future features or on the performance of the Services beyond what is expressly warranted in these Terms.

10. Service Availability

10.1 Availability:

5010AI will use commercially reasonable efforts to make the Platform available and operational. However, the Services are not guaranteed to be uninterrupted, error-free, or available at all times. Availability may be affected by scheduled maintenance, third-party service provider outages, internet connectivity issues, or force majeure events.

10.2 Scheduled Maintenance:

5010AI may perform scheduled maintenance that temporarily limits access to the Services. Where practicable, 5010AI will provide reasonable advance notice of planned maintenance windows.

10.3 Service Level Agreements:

Specific service level commitments, if any, will be set forth in the applicable Order Form or a separate Service Level Agreement. In the absence of such commitments, this Section 10 governs availability expectations.

11. Warranties and Disclaimers

11.1 5010AI Warranty:

5010AI warrants that it will provide the Services in a professional manner consistent with general industry standards. If the Services do not materially conform to the documentation, you must notify 5010AI in writing within thirty (30) days. Upon timely notification, 5010AI will attempt to correct the non-conformance. If 5010AI cannot correct the issue within a reasonable time, you may terminate the affected part of the Agreement and receive a pro-rata refund of prepaid fees. This remedy is your sole remedy for any breach of this warranty.

11.2 Disclaimers:

EXCEPT AS EXPRESSLY PROVIDED ABOVE, THE SERVICES ARE PROVIDED “AS IS” WITHOUT ANY WARRANTY OR CONDITION OF ANY KIND. 5010AI DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. YOU ACKNOWLEDGE THAT AI TECHNOLOGY AND THE UNDERLYING DATA SOURCES HAVE INHERENT LIMITATIONS. 5010AI DOES NOT WARRANT THAT (A) THE SERVICES WILL MEET ALL YOUR REQUIREMENTS; (B) AI-GENERATED OUTPUTS WILL BE ACCURATE, COMPLETE, OR FREE FROM HALLUCINATIONS; (C) DATA FROM THIRD-PARTY SOURCES (INCLUDING FDA, EMA, CLINICALTRIALS.GOV, PUBMED, AND OPENFDA) WILL BE ACCURATE, COMPLETE, OR CURRENT; OR (D) THE SERVICES WILL BE UNINTERRUPTED OR ERROR-FREE.

11.3 No Regulatory, Legal, or Professional Advice:

The Services are not designed to provide regulatory, legal, clinical, medical, financial, or other professional advice. The Platform is an intelligence and analysis tool intended to support, not replace, qualified human decision-making. You agree not to represent or imply that any AI Output or data from the Platform is a substitute for professional advice, independent analysis, or regulatory guidance. You will comply with all laws, regulations, and professional standards in your use of the Services and Outputs. If you provide Platform-derived information to third parties, your agreements with those parties should include appropriate disclaimers regarding the nature and limitations of AI-generated content.

11.4 Customer Sole Responsibility:

You are solely responsible for verifying the accuracy and legality of all Outputs and data accessed through the Platform. You assume all risk from use of the Services. You should implement your own processes to review and validate outputs, including qualified human review by appropriately trained personnel.

12. Limitation of Liability

12.1 Exclusion of Consequential Damages:

TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY WILL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND (INCLUDING LOSS OF PROFITS, LOSS OF DATA, LOSS OF BUSINESS, OR REGULATORY PENALTIES) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE USE OF THE SERVICES, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

12.2 Liability Cap:

TO THE MAXIMUM EXTENT PERMITTED BY LAW, EACH PARTY’S AGGREGATE LIABILITY FOR ALL CLAIMS ARISING UNDER THIS AGREEMENT SHALL NOT EXCEED THE TOTAL FEES PAID OR PAYABLE BY CUSTOMER TO 5010AI IN THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO LIABILITY. This cap applies to all liability, including breach of contract, tort, strict liability, or otherwise. The above limitations shall not apply to (a) damages arising from a party’s gross negligence or willful misconduct, (b) payment obligations, or (c) either party’s breach of confidentiality or infringement of intellectual property.

13. Indemnification

13.1 By Customer:

You will indemnify, defend, and hold harmless 5010AI and its affiliates, officers, and employees from claims, damages, losses, liabilities, and expenses (including reasonable attorneys’ fees) arising out of or related to (a) your violation of these Terms, (b) your misuse of the Services (including breach of Sections 3 or 5 or use outside licensed scope), (c) any dispute between you and a third party concerning your data, content, or outputs, or (d) any regulatory, legal, or compliance consequences arising from your reliance on AI-generated Outputs without appropriate human review.

13.2 By 5010AI:

5010AI will indemnify and defend Customer against any third-party claim alleging that the unmodified Services infringe the intellectual property rights of that third party, provided that (a) you promptly notify 5010AI in writing, (b) 5010AI has sole control of the defense and settlement, and (c) you reasonably cooperate. If an injunction or claim prevents your use of the Services, 5010AI may (at its option) obtain the right for continued use, replace or modify the Services to be non-infringing, or terminate the Agreement and refund unused fees. This states the entire obligation of 5010AI for IP infringement.

13.3 Exclusions:

Neither party’s indemnity obligation applies to the extent a claim arises from the other party’s negligence, misconduct, or breach of these Terms.

14. Term and Termination

14.1 Term:

This Agreement commences on the Effective Date and continues for the term specified in the Order Form (“Term”). Unless otherwise stated, subscription terms auto-renew for successive terms of equal length, unless either party gives notice of non-renewal at least thirty (30) days before the end of the then-current term.

14.2 Termination for Cause:

Either party may terminate this Agreement on written notice if the other party materially breaches these Terms and fails to cure within thirty (30) days after written notice. 5010AI may also terminate or suspend your access immediately if you fail to pay undisputed fees when due, violate any use restrictions or applicable law, or if continued provision of Services would violate applicable law.

14.3 Effect of Termination:

Upon any termination, all outstanding payment obligations become due immediately. 5010AI will disable your access to the Services. Subject to Section 6.3, 5010AI will delete or return your data upon written request within thirty (30) days. Sections on Confidentiality (7), Warranties and Disclaimers (11), Limitations (12), Indemnification (13), Governing Law (16), and Miscellaneous (17) will survive termination.

14.4 No Further Liability:

Upon termination, 5010AI will have no obligation to provide support or deliver unused features. Termination does not limit either party from pursuing other remedies for breach.

15. Compliance with Laws and Export Controls

15.1 General Compliance:

You agree to comply with all applicable laws and regulations in connection with your use of the Services. This includes data privacy and protection laws, pharmaceutical and healthcare regulations, and any industry-specific rules applicable to your use of regulatory intelligence tools.

15.2 Export Controls:

The Services and any underlying technology may be subject to export control laws and economic sanctions. You agree not to export, re-export, or transfer any portion of the Services to any country or person prohibited by applicable law. You represent and warrant that you are not located in, under control of, or a national of any embargoed country, nor are you a sanctioned party.

15.3 Anti-Bribery:

Each party will comply with all applicable anti-corruption and anti-bribery laws (e.g., the U.S. Foreign Corrupt Practices Act and UK Bribery Act).

15.4 Local Laws:

If you access or use the Services outside the United States, you do so on your own initiative and must comply with local laws. 5010AI does not guarantee the Services comply with laws of jurisdictions other than those explicitly addressed herein.

16. Governing Law and Dispute Resolution

16.1 Governing Law:

This Agreement will be governed by and construed in accordance with the laws of the State of Delaware, USA (excluding its conflicts-of-law rules), and applicable U.S. federal law. The United Nations Convention on Contracts for the International Sale of Goods is expressly excluded.

16.2 Dispute Resolution:

Any dispute arising under this Agreement will be subject to the exclusive jurisdiction of state or federal courts located in New Castle County, Delaware. Each party consents to such jurisdiction and venue and waives any objections. Notwithstanding the foregoing, 5010AI may seek equitable relief in any court of competent jurisdiction to protect its intellectual property or confidential information.

16.3 Attorneys’ Fees:

In any action to enforce this Agreement, the prevailing party will be entitled to recover its reasonable attorneys’ fees and costs.

17. Miscellaneous

17.1 Entire Agreement:

This Agreement (including all Order Forms, Schedules, and DPAs) constitutes the entire understanding between you and 5010AI concerning the Services and supersedes all prior agreements. No amendment or waiver is effective unless in writing signed by both parties.

17.2 Assignment:

You may not assign or transfer this Agreement without 5010AI’s prior written consent (and any unauthorized assignment is void). 5010AI may assign this Agreement without your consent to an affiliate or in connection with a merger or sale of assets.

17.3 Force Majeure:

Neither party will be liable for any delay or failure to perform caused by events beyond its reasonable control (e.g., natural disasters, war, epidemics, government actions, third-party service provider outages). The affected party will promptly notify the other and resume performance as soon as practicable.

17.4 Notices:

All notices under this Agreement must be in writing. 5010AI may provide notices to you via email or publication on its website; notices to 5010AI should be sent to the address specified in your Order Form or the contact information provided by 5010AI.

17.5 Severability:

If any provision of this Agreement is held invalid or unenforceable, the rest of the Agreement remains in effect.

17.6 No Third-Party Beneficiaries:

This Agreement is for the benefit of you and 5010AI only. Nothing herein grants any right or remedy to any other person or entity.

17.7 Waiver:

No failure or delay by either party in exercising any right hereunder will operate as a waiver of that right.

17.8 Interpretation:

Section headings are for convenience and do not affect interpretation. “Including” and similar terms are not limiting; “or” is disjunctive.

17.9 Changes to Terms:

5010AI may update these Terms from time to time. Material changes will be communicated to you via email or through the Platform at least thirty (30) days before taking effect. Your continued use of the Services after the effective date of updated Terms constitutes acceptance. If you do not agree to updated Terms, you may terminate the Agreement in accordance with Section 14.

By signing an Order Form or by using the 5010AI Platform, you acknowledge that you have read and understand these Terms and agree to be bound by them.